Trends in O&#038;P

[caption id="attachment_243546" align="aligncenter" width="1506"] Photograph courtesy of PSYONIC.[/caption] New developments are proliferating in many areas of prosthetic technology and research including bionics, robotics, materials science, osseointegration, microprocessor devices, and 3D printing. However, these advances do not occur in a vacuum, but in a matrix that involves all these areas as well as neuroengineering, rehabilitation, biomedical engineering, technology transfers from university research labs to commercialization, and more. In this feature, we touch on some of them. Patient Care Present technology generally focuses on improving patients’ function, comfort, and device satisfaction and thus restoring their quality of life and ability to enjoy their previous lifestyles as much as possible. The goal, however, is to develop prosthetic limbs that feel and function as closely to a healthy natural limb as possible. As the profession has adopted regular utilization of validated outcomes in the clinic, treatment plans can be increasingly based on outcomes-based research rather than isolated clinician experience or bias. O&P needs “more science behind what we’re doing,” says Kevin Carroll, MS, CP, FAAOP/D, vice president of Lower Extremity Prosthetics, Hanger Clinic. When asked about trends in consumer demand for high-tech upper- and lower-limb prostheses, Phil Stevens, MEd, CPO, FAAOP, a Hanger Clinic upper-limb prosthetic specialist and a director of Clinical and Scientific Affairs within the Hanger Institute for Clinical Research and Education, echoed Carroll’s sentiments, “It’s the continued development of the supportive evidence behind those technologies. We’re shifting the emphasis from the technology to the outcomes associated with the technology. That’s a big shift in thinking, but it’s essential that we view our profession in terms of the outcomes our patients ultimately experience.” Clinical Practice Guidelines Another approach to improving patient care is the development and proliferation of clinical practice guidelines (CPGs). These resources, well-established in many areas of healthcare, are beginning to flourish in O&P. “Clinical Practice Guidelines are common in healthcare and our field is catching up,” says Stevens. “The essence of CPGs is to help clinicians make evidence-based decisions that other-wise would require a clinician’s time, access to research, patience, and a certain skill set.” [caption id="attachment_243547" align="alignleft" width="300"] A user demonstrates the Psyonic Ability Hand’s strength while doing push-ups. Photograph courtesy of PSYONIC.[/caption] Startups Take New Tech From Lab to Market Via technology transfers, university research often spins off innovative ideas into products and processes that can be successfully commercialized. For instance, PSYONIC, a startup that developed the Ability Hand, a functional and affordable prosthetic hand with feedback sensors in the fingertips, has garnered an impressive number of awards and grants. It is made with inexpensive silicones and rubbers that help lower the price to a point that Medicare covers it, which enabled PSYONIC to expand access to 75 percent of people with upper-limb differences in the US, Founder and CEO Aadeel Akhtar told the Polsky Center for Entrepreneurship and Innovation at the University of Chicago. Besides silicone and rubber, the hand also utilizes 3D-printed plastics and carbon fiber. “The multiarticulated fingers have 3D-printed flexible bones that are highly impact-resistant, enabling the hand to survive breaking boards on fire, punching ice blocks, falling from 30 feet in the air, and even tumbling around in a dryer for ten minutes,” Akhtar says. “We also 3D print our palms to allow for complex structures to house the motors and electronics in the hand but reinforce it with carbon fiber to keep it light and strong.” He adds, “We are definitely considering smaller pediatric versions. We already recommend our hand for ages 13-plus and have had users as young as ten.” The Android/IOS mobile apps are used by clinicians and end-users to configure settings for the hand by adjusting the sensitivity of the muscle and touch sensors, customizing grips and button actions, switching between control systems, and receiving over-the-air software updates to the hand. The apps offer some fun for users too, he says. “We even have hidden Easter eggs. For example, there’s an invisible button in the top right of the demo screen that if you hit it, will put the hand in rock mode and start playing 8-bit music from the motors.” “As of November 2022, the Ability Hand is available for researchers worldwide, and we are working toward making it available clinically worldwide by next year,” he says. The company moved from Illinois to California in August 2022 to work with the Navy Hospital, the University of California San Diego, and the Challenged Athletes Foundation on the next generation of bionic devices, including osseointegration, nerve implants for individual finger control and sensory feedback, as well as the development of an Ability Leg, now in early development. “The goal is to make the Ability Leg ready for a triathlon in the next five years,” Akhtar says. Phantom Neuro Improves Device Control Emerging from a research laboratory at the Johns Hopkins University School of Medicine, Phantom Neuro is a neurotechnology company that is enabling lifelike control of robotic orthopedic technologies, such as prosthetic limbs and exoskeletons. Phantom’s solution, the Phantom X, consists of low-risk implantable sensors, artificial intelligence, and enabling software. Cofounder and CEO Connor Glass, MD, the primary inventor of the Phantom X, completed his medical training at the University of Oklahoma College of Medicine, followed by a research fellowship in Plastic Surgery and Biomedical Engineering at Johns Hopkins University. During his research training, he and Johns Hopkins co-inventors Sami Tuffaha, MD, director of peripheral nerve surgery within the Plastic Surgery Department, and Nitish V. Thakor, PhD, professor of biomedical engineering, created Phantom’s foundational technology. For prosthesis users, Phantom Neuro’s system aims to wirelessly recreate the natural signaling pathways people with intact limbs use to control muscle movement. Sensors on muscles transmit the movement signals to a phone or other internet-enabled device; the signals are then converted into commands for the targeted prosthesis in real time. A video on Phantom Neuro’s website shows the process in steps with more detail: Phantom’s flexible sensor device is thinner than 3mm and is inserted under the skin through a small incision. There it can detect the electrical activity of underlying muscles, which is transmitted wirelessly out of the body, decoded into intended movements, and then enacted into a prosthesis or exoskeleton. The result is robotic technology that mimics human movement in real time. [caption id="attachment_243548" align="alignright" width="300"] The Coapt pattern recognition control system is shown in a myoelectric upper-limb prosthesis with a clear cover. Photograph courtesy of Coapt.[/caption] Control Strategies for Myoelectric Prostheses Referring to myoelectric and powered prosthetic devices, Andreas Kannenberg, MD, PhD, executive medical director North America, Ottobock Healthcare, says, “The entire industry should do more to educate and train patients to use these prostheses, as the integration of power in the neuromuscular control of lower-limb walking and upper-limb voluntary control is not intuitive for most patients. I think that is also the biggest obstacle to the adoption of new technology.” Another promising research paper, “Intuitive Real-time Control Strategy for High-density Myoelectric Hand Prosthesis Using Deep and Transfer Learning,” published in Nature in 2021, agrees with Kannenberg, noting that studies with prosthesis users found that a lack of intuitiveness and ease-of-use in the human-machine control interface are among the main driving factors in the low user acceptance of myoelectric hand devices. The researchers present an alternative that uses surface high-density electromyography (EMG) and a convolutional neural network-based gesture recognition system to adapt itself to each user’s voluntary muscle contraction patterns. A transfer learning approach drastically reduces training time and allows for easy installation and calibration processes, according to the authors. Based on the concept of musculoskeletal modeling as an alternative to widely used machine-learning methods, a prosthetic limb control strategy from the University of Twente, The Netherlands, in cooperation with Ottobock, was demonstrated at the 2022 international congress Rehab Week. After creating a detailed digital model of a person’s leg and recording EMG signals from multiple sites in the leg muscles, the research then used the signals to determine how virtual muscles in the model would activate and generate force in the leg joints. The predicted movement forces were then transmitted to the robotic prosthesis in real time. [caption id="attachment_243549" align="alignleft" width="300"] A military veteran holds a photo of himself when on active duty, using his Open Bionics Hero Arm. Photograph courtesy of Open Bionics.[/caption] Coapt produces a pattern recognition-based myoelectric upper-limb control system. In 2012, some of the researchers took on the challenge of starting the company and spinning out the technology they had been working on. “Since then, it has been a constant road of growth and learning, and along the way, the power of this technology speaks for itself to anyone who experiences it. Because of that, our burden has not been in proving it, but rather in introducing it,” says Blair Lock, co-founder and CEO. “Our field practitioners barely have a spare moment, and most don’t have much time to incorporate something completely novel that wasn’t part of their education.” Although keeping a strong focus on its core product line, the company has continued to reinvest in its resources, operations, and research, Lock says. For the next ten years, “connectivity is key,” Lock says. “Tools and data never available to us before are powering our new era of research and development. Our connected health technologies are poised to provide the wearers with new ownership of their device control story while empowering clinicians for more informed and efficient care.” [caption id="attachment_243551" align="alignright" width="300"] The PodoPrinter SOLE uses a conveyor-belt 3D printer to produce custom insoles. Photograph courtesy of PodoPrinter.[/caption] PodoPrinter, based in The Netherlands, offers an all-in-one 3D-printing solution for the podiatric market. “We supply a complete solution from CAD design to the final 3D-printed custom insole,” says Sascha Luijit-Luder, business development manager. The system includes the SOLE conveyor-belt 3D printer, the SOLE Premium filament from ColorFabb, and the specialized PodoCad design program. The filament is available in black and several other colors, and purchasers only need a 2D- or 3D-scanner to use the system, Luijit-Luder says. “The PodoCAD software is the easy-to-use design program to create your custom designed insoles within two to four minutes.” Because of the unique, patented, conveyor-belt design of the SOLE printer, users can print on a large scale, 24/7 production time without needing an operator, according to Luijit-Luder. Luijit-Luder describes the backstory. “From the pioneering phase sometime in 2016, the predecessor of the current PodoPrinter, Blackbelt 3D, was developed. Through this printer we came into contact with the podiatric market, after which we started developing the printer for this niche segment in 2019.” The launch took place at the end of 2020 after the workflow and output had been validated, and the company, owned by Stephan Schürmann, inventor, Job Windhorst, and Ruud Rouleaux, began building its team. Luijit-Luder says, “We have entered the scaling-up phase, and we are aiming for worldwide coverage in terms of services.” Open Bionics brings sunshine and superheroes to their multigrip 3D-printed Hero Arm. The company has partnered with Disney, LucasFilm, Marvel, and others to offer a range of Hero Arm covers inspired by children’s—and some adults’—favorite characters. Other cover designs are also available. The company’s goal is developing affordable, assistive devices that enhance the human body, according to Julianna Garbo, US marketing manager. The company, founded in 2014 by Joel Gibbard and Samantha Payne, MBE, is known globally for using 3D printing and 3D scanning, along with innovative software and design, to make advanced, affordable, and accessible bionic limbs, Garbo says. Gibbard began tinkering with robotic hands and 3D-printed prostheses at age 17. “He was fascinated by the movement of a disembodied humanoid hand,” says Garbo. “After some prototypes and many crates of failures, thinking of robotic hands as a medical device, he met Samantha, who was thinking about robotic hands in a more wearable-tech way to make it look cool for the people wearing it, as most prostheses up until then would try to mimic the appearance of the limb.” Combining their concepts led to Open Bionics. After meeting with a group of people with limb loss to get their perspectives on what would be the best solutions for prostheses and understanding their journeys on trying to find the best prosthetic solution for themselves, choosing the 3D printing system seemed to be the best approach to make devices that could be not only cheaper and lighter, but also could be made more quickly. In 2022, the company launched the Sidekick app, which helps Hero Arm users adjust to the bionic arm by helping with muscle exercises, performance data, and arm movements. The team includes 40 people in the UK and ten in the US. Looking to the future, Payne and Gibbard raised more than $5 million in 2019 to serve multiple international markets and deliver their prosthetic technology to people with limb loss and limb differences in the US. Today, the Hero Arm is available in the UK, Europe, and the US. To be ahead of the curve bringing high-tech yet affordable solutions to the prosthetic world, Open Bionics also hopes to broaden its presence, expanding the access to the Hero Arm to more people worldwide. [caption id="attachment_243552" align="alignright" width="300"] Sanders displays the auto-adjustable prosthetic socket she and her team developed. Photograph by Kiyomi Taguchi/UW News.[/caption] UW Develops Self-adjustable Lower-limb Prosthesis Adjustable sockets free people with amputations from having to change sock plies or adjust other padding throughout the day as the residual limb volume changes. In a breakthrough, the University of Washington (UW) developed an auto-adjustable prosthetic socket, which adjusts the size automatically without the user having to do it consciously. “Very small changes in the size of a person’s residual limb change how the prosthesis feels,” Katheryn Allyn, CPO, FAAOP, a professor of bioengineering in Joan Sanders’ lab, says in a UW news release. “Over the day, the socket may become uncomfortable and cause pain, instability, compensatory strategies, or injury to the user.” [caption id="attachment_243553" align="alignleft" width="257"] A close-up of the prosthetic socket. Photograph by Kiyomi Taguchi/UW News.[/caption] Sensors work with motor-driven panels within the socket to tighten or expand throughout the day, with small adjustments that are often undetectable by users. After successful lab tests, the socket is being tested by research participants at home and a new clinical trial is underway. A $6 million Joint Warfighter Medical Research Program grant from the US Department of Defense “allowed us to hire a lot of people to focus on a very innovative idea,” Joan Sanders, PhD, says in the news release. The idea emerged in part from an article in a NASA magazine read by Christian Redd, then one of the bioengineering doctoral students, describing a new sensing chip and antenna that he thought might be applied to monitor sock thickness. “We later realized that it could be used to detect socket fit,” Sanders says. The team has filed for a patent on the innovation. Now with a new grant, the Sanders lab and collaborators are testing the technology at the US Army’s Center for the Intrepid (CFI) in San Antonio, Texas. Working with Lee Childers, PhD, MSPO, CP, CFI’s principal investigator, and his team, the group is testing the auto-adjusting socket in the Computer Assisted Rehabilitation Environment (CAREN) using a simulated ambush setting and in a military functional evaluation test called the Functional Capacity Evaluation–Military. Looking Ahead Looking forward, technology continues to advance in O&P as well in related areas that fuel these advances, despite the COVID-19 pandemic, supply chain issues, and world turmoil. An influx of younger people bringing their energy, enthusiasm, and innovative ideas are joining older ones who bring their experience, expertise, and their own innovative ideas to the table. Although this feature could only include some of them, developments in so many areas in O&P research and development and technology offer better patient care now, and as they progress, O&P systems are drawing ever more closely in function, intuitive movement, and sensory perception to those of a natural healthy limb. Miki Fairley is a freelance writer based in southwest Colorado. She can be contacted at miki.fairley@gmail.com .

Trends in O&P

Technology and Research Move Ahead for Better Patient Care

Editor’s Note–January 2023

OHI Secures Private Equity’s Majority Investment

OHI Secures Private Equity’s Majority Investment

O&P JOBS

HH Manager, Orthotics & Prosthetics

Orthotics and Prosthetics Assistant

Certified Orthotist — Full-Time or Part-Time, Pediatric Practice

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Trends in O&P

Technology and Research Move Ahead for Better Patient Care

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Editor’s Note–January 2023

OHI Secures Private Equity’s Majority Investment

OHI Secures Private Equity’s Majority Investment

O&P JOBS

HH Manager, Orthotics & Prosthetics

Orthotics and Prosthetics Assistant

Certified Orthotist — Full-Time or Part-Time, Pediatric Practice

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